Guaifenesin 600 mg
- Product NDC
- 51316-008
- 11-digit product format
- 513160008
- Labeler code
- 51316
- Product ID
- 51316-008_0f020bff-5cb6-4169-5caa-fceeb1f30813
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Guaifenesin
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- CVS Pharmacy
- Application
- ANDA215932
- Marketing category
- ANDA
- Marketing start
- 2022-09-01
- Substance
- GUAIFENESIN
- Active strength
- 600 mg/1
- Pharmacologic classes
- Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Guaifenesin 600 mg
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| GUAIFENESIN | 600 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 495W7451VQ |
| Rxcui | 636522 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51316-008-01 | Guaifenesin 600 mg | 5 in 1 CARTON | TABLET, EXTENDED RELEASE | 5 | | 5 |
| 51316-008-01 | Guaifenesin 600 mg | 20 in 1 BLISTER PACK | TABLET, EXTENDED RELEASE | 20 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51316-008 | GUAIFENESIN 600 MG (GUAIFENESIN ) TABLET, EXTENDED RELEASE [CVS PHARMACY] | 5 | Current NDC, Legacy NDC, 2 package rows | 20241113_ed242994-facd-750e-b7e1-2eec42c1f65f.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 51316-008-01 | 51316000801 | 5 BLISTER PACK in 1 CARTON (51316-008-01) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | 5 blister pack | 2023-05-01 | No | No | Historical |